Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project

Background The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life. Methods This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called “Friends in Nature” or to the control group. “Friends in Nature” uses modifications of the “Circle of Friends” methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed. Discussion The three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections. Trial registration Barcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022. Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022. Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022. Supplementary Information The online version contains supplementary material available at 10.1186/s12889-023-17547-x.

to a weakened state of health and to the risk of premature death.Experiences of loneliness are common among elderly people in long-term care, more than a third suffer from loneliness at least sometimes.The COVID-19 pandemic has limited the living environment of elderly people and increased loneliness, especially in service homes.However, the effect of nature experiences on the alleviation of loneliness in elderly people has not yet been studied, so research related to the topic is needed.
The purpose of the study is to find out the loneliness experienced by the elderly living in a service home and the importance of nature experiences for their well-being.The study finds out what kind of loneliness the subjects experience in a service home, how the subjects feel that loneliness affects their well-being, and in what ways, in their opinion, loneliness can be prevented, alleviated and reduced through nature experiences.In addition, the research investigates the experiences of the subjects of nature-based group rehabilitation.
The study will include 16-25-year-old people living in Helsinki's care homes who experience loneliness.They are offered group activities based on nature experiences ("Circle of Friends").The research is carried out in the subjects' own service buildings, in Helsinki, Finland.
The nature-oriented Ystäväpiiri group offered in the study meets in the subjects' own service center once a week, at the same time each week a total of 9 times.The group is led by trained group leaders who take notes on group situations for research.6-10 elderly people participate in one Ystäväpiiri group.The group's goal is shared nature experiences and through them alleviating loneliness, supporting friendships and a comfortable time together.In the group, we have coffee, carry out nature experiences according to the wishes of the participants and discuss issues of interest to the participants.

How to research
The research is carried out as a qualitative interview and observation study.At the beginning of the study, the background information, well-being and health of the subjects are surveyed using a questionnaire.
Participation in the study takes about six months.The research includes participating in a nature-oriented Ystäväpiiri group for three months.
The research is carried out in such a way that the researcher interviews your next of kin individually 2-4 weeks before the start of the Friends Circle group and 2-4 weeks after.
The researcher visits the Ystäväpiiri group to monitor its progress and makes notes on the observations.During the research, the group visits are recorded.Approximately 3-6 weeks after the end of the Ystäväpiiri group, the researcher organizes one more additional group discussion, where experiences in nature-oriented Ystäväpiiri group activities are discussed.From this group discussion, the researcher takes notes for the research.The interviews conducted during the research are recorded.
If your next of kin is interested in the study, we kindly ask you to fill out the attached form and return it to the nurse in his unit.The researcher will contact you personally in the near future and tell you more about the research.After this, you and your next of kin can voluntarily decide if they want to participate in the study.The researchers will only receive the information about your next of kin that he himself gives during the investigation.This information remains for research use.

Termination of research
After the group discussion that takes place after the end of the circle of friends group, the researcher prepares a report from the material he has collected, in which it is not possible to identify the research subjects.Subjects can read the report after it is completed.
From the start of the research to the publication of its results, it is estimated to last five years as a whole, from which time the portion of the researched is estimated to last about six months.

Conductor and financier of the study
The study is carried out by the University of Helsinki and the Hospital District of Helsinki and Uusimaa.The research takes place in Helsinki serviced apartments or enhanced serviced housing units.This qualitative study is carried out by researcher Laura Rautiainen as part of her dissertation research.The person responsible for the study is professor emerita Kaisu Pitkälä, who is responsible for the safety of the research subjects.The research commission is the University of Helsinki.

Research costs and financial statements
The University of Helsinki and the EU-funded RECETA Project are responsible for funding the research.The RECETAS project pays the research center compensation for carrying out the research.Research nurses are paid a separate compensation for conducting research.

Possible benefits and risks of research
The potential benefit of the research is that the loneliness of elderly people who participate in the nature-oriented Ystäväpiiri group will be alleviated, their health-related quality of life will improve, their memory will improve, and this will also be reflected in their health and well-being.Subjects are at particular risk of the harms of loneliness and isolation, such as declines in well-being, health and memory, and thus the benefits they receive can be great.Likewise, by participating in research, they have the opportunity to participate in nature experiences that may be particularly well-being enhancing.

Possible disadvantages and inconveniences caused by the study
This study will not cause any harm to your next of kin, nor does it involve special risks or significant discomfort.The content of the nature-oriented Ystäväpiiri group is planned according to the wishes of the elderly people participating in the group and on their terms.If necessary, the study doctor assesses the subjects' condition after the research nurses' examinations and before the start of the group, so that the subjects are not exposed to risks due to their illnesses.If diseases that require a doctor's examination come up during the examination, this will be reported to the service center and the responsible home care doctor.
The safety of the research subjects is guaranteed on excursions with the disabled and by several escorts, including volunteers.Group activities and their applicability are tested before large-scale interventions begin.Potentially experienced disadvantages, injuries, hospitalizations of the subjects will be monitored throughout the group activity and 9 months after.
You can ask researcher Laura Rautiainen or research doctor Kaisu Pitkälä in more detail about possible effects and harms.

Insurance coverage and compensation of the research subjects
If your close relative suffers personal injury as a result of participating in the study, you can apply for compensation.For personal injury, you can apply for compensation from the research center's patient insurance.Kaisu Pitkälä provides more information about the insurance and applying for it (contact information below).
There is no remuneration for participating in this study.Participating in the nature-oriented Ystäväpiiri group, which is part of the study, is free for your close family members.

Personal data processing and data confidentiality (briefly)
In this study, Finnish research and personal data protection legislation is applied.
Researchers and other research personnel are committed to following good scientific practice and research ethical guidelines.A more detailed description of the research's right to information basis is at the end of this release.
The personal data of your next of kin is processed for scientific research purposes.The information and research results collected about him are treated confidentially as required by legislation.All entities and persons handling the information of your immediate family are bound by confidentiality.You can find more information about personal data processing and rights at the end of this announcement.

DESCRIPTION OF THE PROCESSING OF PERSONAL DATA IN THE RESEARCH AND THE RELATED RIGHTS OF THE RESEARCHER Registrar
The registry keeper in the study is HY, which is responsible for the legality of the processing of personal data in connection with the study.
Only personal data necessary for the purpose of the study are stored in the research register.Data collection is based on a research plan.

Basis for processing personal data
In this study, it is a general interest in other scientific research: The basis for processing personal data for the purpose of scientific research in the public interest is Articles 6.1.eand 9.2.j of the Data Protection Regulation, which is regulated in more detail in the law on medical research (L 488/1999).
Section 6 subsection 2 of the Data Protection Act applies when processing the personal data of your next of kin in research.

Processing of personal data
In the study, the personal data of your next of kin will be processed only by the persons appointed to the research group, whose job duties include processing them.
Only personal data necessary for the purpose of the study are stored in the research register.The identity of the research subjects is known only to the research staff, who are bound by confidentiality.All information collected about your next of kin in the study is processed coded after the data collection, so his or her information cannot be identified from research results, reports or publications related to the study.Coding the data means that your next of kin's name and social security number are removed and replaced with a unique code.After this, information about him cannot be identified without a code key, which is kept by the person responsible for the study.Persons outside the study do not have access to the code key.The research results are analyzed coded.

Where data is collected
The study collects personal information about your next of kin from the following sources: a letter survey at the beginning, individual interviews conducted by the researcher before and after the group, a group interview after the group, the group leaders' notes about the groups, and the researcher's observations in the group from two group sessions.The interviews conducted during the research and the observations carried out in the group will be recorded.

Transfer of personal data
In this study, the research data will be transferred without identifying information to the EU joint RECETAS project for analysis.The personal data of your immediate family will not be disclosed to other parties and will be processed for scientific research purposes.The data of your immediate family will not be transferred outside the EU and the European Economic Area (EEA).

Storage of personal data
The retention period of personal data is regulated by legislation and good clinical research practice.HY is responsible for the storage of your close relatives' personal data.
This study is an observational interview study in nature.Personal data will be destroyed no later than 10 years after the end of the research.In order to verify the accuracy of the research results, it is recommended to keep the data for a predetermined period of time after the end of the research.

Subject's rights
You have the right to receive information about the processing of personal data of your next of kin and to request the restriction of the processing of personal data.You also have the right to check his information and request that it be corrected or completed if, for example, you notice an error in it or that it is incomplete or inaccurate.You also have the right to object to the processing of the personal data of your next of kin.
However, in the context of scientific research, these rights can be limited.The law may oblige the data controller to keep your research data for a certain period of time, regardless of the data subject's rights.The law allows exceptions to the data subject's rights when it is necessary to ensure the safety of scientific research results and research subjects.In this study, these exceptions do not apply.
You can inquire at any time whether we process the personal data of your next of kin and demand a justification for the processing.You can also inquire about where we got his information from and where his information has been transferred.You have the right to receive the information free of charge and within a reasonable time (within one month of the request).If your Data Request is very extensive or for some other justified reason the collection of data is particularly time-consuming, the deadline can be extended by a maximum of two (2) months.You will be notified of the extension of the deadline and the reason.
In matters of data protection, we recommend contacting the data protection officer of the research registrar: My close relatives[subject's name]has been asked to participate in the scientific research mentioned above, the purpose of which is to find out the loneliness experienced by the elderly living in a service home and the importance of nature experiences for their wellbeing.The aim of the study is to find out what kind of loneliness the subjects experience in a service home, how the subjects feel that loneliness affects their well-being, and in what ways, in their opinion, loneliness can be prevented, alleviated and reduced through nature experiences.The interviews conducted during the research and the researcher's visits to the group are recorded.
I have read and understood the research bulletin I received and I give my consent to the research according to it.I have received sufficient information from the bulletin about the study and the collection, processing and disclosure of data to be carried out in connection with it.The contents of the release have also been told to me orally and I have received sufficient answers to all my questions regarding the research.The information was provided by researcher Laura Rautiainen date].
I have had enough time to consider my next of kin's participation in the study.I have received sufficient information about the purpose of the study and its implementation, the benefits and risks of the study, and my rights.I have not been pressured or enticed to give permission to participate in the study.
I know that the information of my next of kin will be treated confidentially and will not be disclosed to outsiders.
I understand that participation in this study is voluntary.I am aware of the fact that I have the right to deny my immediate family participation in the study.Later, if my next of kin wishes, I can also interrupt his participation in the study or withdraw my consent at any time without giving a reason, and these will not affect the treatment of my next of kin or the treatment he receives in any way.
I can stop the participation of my next of kin at any stage of the study without giving a reason.I also have the right to withdraw my consent at any time before the end of the study.I am aware that if I interrupt research or withdraw consent, the information collected about my next of kin up to the time of suspension and withdrawal of consent can be used in the research.I know that no compensation will be paid for the expenses incurred for participating in the study.The original signed document remains in the researcher's archive and a copy of the signed consent is given to the subject's representative.
You have the right to file a complaint, especially with the supervisory authority corresponding to the location of your next of kin's permanent residence, if you consider that the processing of personal data violates the EU General Data Protection Regulation (EU) 2016/679 or the Data Protection Act (1050/2018).In Finland, the supervisory authority is the Data Protection Commissioner.Office of the Data Protection Commissioner, Lintulahdenkuja 4, 00530 Helsinki, PO Box 800, 00531 Helsinki Telephone exchange: 029 566 6700, E-mail (register office):data protection@om.fiCONSENTOF THE SUBJECT'S CLOSE RELATIVE TO PARTICIPATION IN THE RESEARCHElderly people's experiences of loneliness and the importance of nature in assisted living Helsinki, researcher Laura Rautiainen With my signature, I confirm the participation of my next of kin in this study and my consent to voluntarily become a research subject.